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WHAT ARE THE IMPLICATIONS OF THE EU CLINICAL TRIALS REGISTER?

The European Union (EU) Clinical Trials Register was launched in March following over a year of delays, bringing together details on all clinical trials taking place in the EU member states plus Iceland, Liechtenstein and Norway for the public to access.

Created by the European Medicines Agency (EMA), the register features information from trials database EudraCT, supplemented by the clinical trial approval and relevant ethics committee opinions.

Trials conducted by both industry and research institutes will be detailed on the register and people can use the search function to filter the trials by disease, drug name, sponsor, country, age group, gender, trial phase, trial status and date range, meaning it is simple to pull up any information you may need.

At the start of April, a week after the registry went live, there were over 5,000 trials detailed, and it is hoped that in time all trials which have taken place since 2004 will be included. This would be a vast number, as approximately 4,000 new trials are approved in the EU each year, and last on average two or three years, meaning around 12,000 are ongoing at any given time.

Why is the information needed?

One question people may be asking is why does all this information need to be accessible to the public and the answer is transparency. If all the data is easily available in one place, people can see what trials are going on anywhere in Europe and can possibly give more people access to potential new treatments.

Commenting, Lise Murphy, co-chair of the Agency's Working Party with Patients' and Consumers’ Organisations said: "We welcome the launch of the EU Clinical Trials Register. It increases transparency of medical research and will make it much easier for patients to find information about clinical trials taking place in Europe. We are committed to continue working with the EMA to further develop the system so that it becomes a valuable and useful resource for patients across the EU."

As well as providing benefits to patients, the register will also aid the research and medical communities by keeping them informed and helping avoid the unnecessary duplication of trials.

John Dalli, European commissioner for health and consumer policy, said: "The register launched is good news for patients as it will allow them to get easier information about clinical trials going on in the EU, possibly giving access to important new treatment. It is also of great interest to healthcare professionals and carers, the research community and industry."

Further improvements

While the registry has garnered praise from a number of quarters since it was unveiled in March, the EMA is quick to highlight that it is not yet a finished product. The body has announced plans to continue work with stakeholders to improve the functionality of the registry, by both enhancing the quality of the data stored and working on the search tool.

In the future there are also plans to feature summaries of trial results, in a similar manner to the US registry ClinicalTrials.gov. It is hoped this feature will be live by the end of 2012, giving patients even more knowledge of the trials going on in the UK.